NCT05459870

Brief Summary

The purpose of this study is to assess the feasibility, safety and efficacy of CAR-T cell therapy in patients with autoimmune disease. Another goal of the study is to learn more about the safety and function of the CAR-T cells and their persistency in autoimmune disease patients.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
44mo left

Started Jun 2027

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
4.9 years until next milestone

Study Start

First participant enrolled

June 1, 2027

Expected
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

2.6 years

First QC Date

July 12, 2022

Last Update Submit

August 25, 2026

Conditions

Autoimmune Diseases

Keywords

CAR-Tautoimmune diseaseautoantibodyCD19BCMACD138BAFF-R

Outcome Measures

Primary Outcomes (1)

  • Safety of 4SCAR T cells in patients with autoimmune diseases

    Safety of 4SCAR T cells in patients with autoimmune diseases using CTCAE 5 standard to evaluate the level of adverse events

    12 weeks

Secondary Outcomes (2)

  • B cell and immunoglobulin suppression activity of 4SCAR T cells in patients with autoimmune diseases

    1 year

  • B cell and immunoglobulin suppression activity of 4SCAR T cells in patients with autoimmune diseases

    1 year

Study Arms (1)

4SCAR T Cell Therapy for autoimmune diseases

EXPERIMENTAL
Biological: 4SCAR T cells

Interventions

4SCAR T cellsBIOLOGICAL

Infusion of 4SCAR T cells at 10\^6 cells/kg body weight via IV

4SCAR T Cell Therapy for autoimmune diseases

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age older than 18 years.
  • expression of B cell surface molecules.
  • the KPS score over 80 points, and survival time is more than 3 months.
  • greater than Hgb 80 g/L.
  • no contraindications to blood cell collection.

You may not qualify if:

  • accompanied with other active diseases and difficult to assess treatment response.
  • bacterial, fungal, or viral infection, unable to control.
  • living with HIV.
  • active HBV or HCV infection.
  • pregnant and nursing mothers.
  • under systemic steroid treatment within a week of the treatment.
  • prior failed CAR-T treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

Location

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Lung-Ji Chang, PhD

CONTACT

+86 0755-86573763c@szgimi.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 15, 2022

Study Start (Estimated)

June 1, 2027

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)